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The Medical Device Developer's Guide to IEC 60601-1

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Medical Devices Directive

The Medical Devices Directive covers the regulatory requirements of the European Union for Medical Devices. Active implantable devices (e.g. pacemakers, implantable infusion pump) are covered by a separate directive, the Active Implantable Medical Devices Directive.

Compliance with the requirements of the Medical Devices Directive is declared by placing the CE Marking on the product, and supplying the device with a Declaration of Conformity.


The routes to compliance depend on the classification of the product. (Note that the full classification rules are given in Annex IX of the Medical Devices Directive).

Class I devices are low risk. Examples are stethoscopes, hospital beds, wheelchairs. The manufacturer has to produce a technical file, including product test results to relevant standards. In addition, manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.

Class IIa are low-medium risk devices, with examples such as hearing aids, electrocardiographs, ultrasonic diagnostic equipment. As for Class I, the manufacturer produces a technical file, but in addition a conformity assessment must be carried out by a Notified Body, according to one of the following routes (at the manufacturer's choice):

  • Examination and testing of each product or homogenous batch of products
  • Audit of the full quality assurance system (EN 46001)
  • Audit of the production quality assurance system (EN 46002)
  • Audit of final inspection and testing (EN46003)

Class IIb are medium-high risk devices, with examples such are surgical lasers, infusion pumps (non-implantable), ventilators, intensive care monitoring equipment. Routes to compliance are the same as for Class IIa, with the addition of Type Examination of the product by the Notified Body, except for the full quality assurance route (EN 46001), where Type Approval is not necessary.

Class III devices are high risk. Examples are balloon catheters, prosthetic heart valves. Routes to compliance are:

  • Audit of the full quality assurance system (EN 46001) and examination of the design dossier by the Notified Body
  • Type Examination of the product together with
    • examination and testing of each product or homogenous batch of products  or
    • audit of the production quality assurance system (EN 46002)


Most of the routes to compliance above require the involvement of a Notified Body. A Notified Body is an organization appointed by the national accreditation authorities and "notified" to the European Commission to approve products covered by the Medical Devices Directive.


For all Classes a Technical File must be prepared, demonstrating compliance of the device with the directive's essential requirements. Compliance can be assumed by showing conformity to the appropriate standards listed by the European Union as Harmonised Standards for the Medical Devices Directive.

Products shipped must bear the CE marking to show compliance with the directive. If a Notified Body is involved in the approval, the number of the Notified Body must also appear adjacent to the CE marking.

Additionally, the product must be shipped with a Declaration of Conformity, an example of which appears below.


EC Declaration of Conformity

Council Directive 93/42/EEC concerning medical devices

 

We    (Name and address of manufacturer)    

Certify that the product described is in conformity with the applicable provisions of Council Directive 93/42/EEC concerning medical devices.

      (Name, type or model, lot, batch or serial no. etc.)   

      (Description)                                                           

 

 

(Name of Responsible Person)    (Signature of Responsible Person)

 (Date)

 

 

 

FDA

Medical Devices Directive

Technical File

Other Countries

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.